Recall Z-2715-2024 ยท IZL System, X-Ray, Mobile
NeuroLogica Corporation
GM60A. Digital Diagnostic Mobile X-Ray System.
| Date | Aug 22, 2024 (initiated Jul 8, 2024) |
| Status | Open, Classified |
| Reason | Potential for the anti-fall system of the device arm to fail. |
| Root cause | Device Design |
| Action | Consignees were emailed an "Urgent -- Medical Device Correction; GM60A Digital X-ray Imaging System" notification the week of 7/8/2024. The notification instructs consignees to share the recall notification with those in their organization that utilize the affected devices and forward the notification if devices have been transferred. Affected systems may continue to be used. Consignees are to check on-hand devices to confirm if they are affected by the field action and return the response form back indicating any devices that require correction by email to fcsa@neurologica.com within 10 busin |
| Quantity | 31 units |
| Distribution | US Nationwide distribution in the states of AR, CT, GA, IN, KS, MA, MD, MO, MS, NC, ND, NJ, NV, OH, PA, VA, WV & DC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150097 | GM60A-32S & GM60A-40S Samsung Electronics Co., Ltd., Feb 19, 2015 |